ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by the numbers '9911205'. The handwriting style is cursive, and the numbers are connected. ### XIV. SUMMARY OF SAFETY AND EFFECTIVENESS ## Allegiance #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRADERM STERILE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM | Manufacturer: | Allegiance Healthcare Sdn. Bhd.<br>Plot 87, Kampung Jawa<br>11900 Bayan Lepas<br>Penang, West Malaysia | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Erica Sethi<br>Allegiance Healthcare Corporation<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 | | Telephone: | (847) 785-3337 | | Date Summary Prepared: | 3/26/99 | | Product Trade Name: | Ultraderm Sterile Latex Surgical Gloves with Protein Content<br>Labeling Claim | | Common Name: | Surgical Glove | | Classification: | Glove, Surgeon's | | Predicate Devices: | Ultraderm Sterile Latex Surgical Gloves | | Description: | Ultraderm Surgical gloves are formulated using natural rubber latex<br>and contain 50 micrograms or less of total water extractable protein<br>per gram | | Intended Use: | Ultraderm Sterile Latex Surgical Gloves with Protein Content<br>Labeling Claim are intended for use in environments within hospitals<br>and other healthcare facilities. The gloves are appropriate for use<br>during invasive and non-invasive medical procedures requiring sterility<br>They are intended to be worn by operating room personnel to<br>protect a surgical wound from contamination. | {1}------------------------------------------------ # K991205 Page 2 | Substantial Equivalence: | Ultraderm Sterile Latex Surgical Gloves with Protein Content<br>Labeling Claim are substantially equivalent to Ultraderm Sterile Latex<br>Surgical Gloves in that they provide the following characteristics:<br>- same intended use<br>- same sizes, configuration, packaging<br>- both made of natural rubber latex using same formulation<br>and manufacturing process<br>- same tensile strength and thickness profiles | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Testing: | | | Test | Result | | Primary Skin<br>Irritation | Biocompatability tests were successfully performed on<br>Ultraderm Surgical Gloves with Protein Content Labeling Claim.<br>Gloves do not display any potential for irritation. | | Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. | | Intracutaneous Reactivity | Gloves show no reactivity. | | Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. | | Guinea Pig Maximization | Gloves do not display any potential for irritation. | | Ultimate Elongation<br>& Tensile Strength | Gloves meet or exceed requirements for rubber surgical gloves<br>per ASTM D3577-98. | | Barrier Defects | Gloves meet or exceed requirements per 21 CFR<br>§800.20, AQL = 2.5. | | Data/Test Method | Gloves meet requirements for protein claim of 50 micrograms or less<br>of water extractable protein per gram using ASTM Lowry test method | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 3 1999 Ms. Erica Sethi Manager, Requlatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGraw Park, IL 60085 Re : K991205 > Trade Name: Ultraderm Sterile Latex Powdered Surqical Gloves With Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: KGO Dated: Auqust 5, 1999 Received: Auqust 9, 1999 Dear Ms. Sethi: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any {3}------------------------------------------------ Page 2 - Ms. Sethi obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Susa Runnon Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K991205". The characters are written in a simple, somewhat rough style, with varying line thickness. The overall impression is that of a quickly written or informal label. Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that resembles a plus sign made up of small dots. The word "Allegiance" is written in a bold, italicized font, with the "A" being larger than the other letters. The overall impression is that of a logo or brand name. Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460 Page 1 of 1 | Applicant: | Allegiance Healthcare Corporation | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K991205 | | Device Name: | Ultraderm Sterile Latex Surgical Gloves with Protein Content Labeling Claim (50 micrograms or less) | | Indications For Use: | These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. | ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE or Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use X Olin S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number